Atrial fibrillation (AF) coincides with coronary artery disease (CAD) shared common risk
factors and pathophysiologic pathways. CAD affects approximately 25% of AF patient according
to the trial Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM), while
in the Global Registry of Acute Coronary Events (GRACE) atrial fibrillation affected about 9%
of patients with CAD. It is reported that approximately 5-8% of the patients who underwent
PCI had concomitated atrial fibrillation.
For AF patients who underwent PCI, both antiplatelet and antithrombotic medications are
required for preventing stent thrombosis and ischemic stroke, leading to an increased risk of
bleeding. Finding a safe and effective balance between the risk of ischaemic events and
bleeding complications is challenged by the shared risk factors for either event such as
advanced age, congestive heart failure, hypertension, diabetes, previous stroke, etc..
Previous pivotal trials have shown that in patients with atrial fibrillation and requiring
antiplatelet treatment, a NOAC plus clopidogrel regimen was associated with a lower incidence
of bleeding events as compared with a warfarin-based triple antithrombotic strategy.
Therefore, the current expert opinions and consensus of North American Societies recommend a
NOAC plus a P2Y12 inhibitor in patients with AF and PCI. However, the NOAC plus clopidogrel
strategy still led to 16.8% of clinically significant bleeding (PIONEER AF-PCI).
Consequently, the compliance of OAC/NOAC is commonly suboptimal among PCI patients who
require an antithrombotic strategy for AF.
Percutaneous left atrial appendage occlusion (LAAO) is a non-pharmacological strategy for
stroke prevention in patients with AF. Both randomized data and registries have confirmed it
can be an alternative to oral anticoagulation in patients with nonvalvular AF. Current
guidelines recommend LAAO for patients with NVAF who have contraindications or are unsuitable
for long-term OAC.
Considering the unique high risk of AF patients with PCI, LAAO may be an attractive treatment
option by obviating the need for combined oral anticoagulation and antiplatelet therapy.
However, so far there is no data from neither randomized cohorts nor real-world registries
showing if LAAO can be a safe and effective alternative strategy compared to VKA/NOAC for
stroke prevention in AF patients who underwent PCI. The PROTECT AF and PREVAIL studies showed
that the percutaneous LAAO was non-inferior to warfarin therapy, and the PRAGUE-17 trial
showed non-inferior to direct oral anticoagulants, however, the small sample size of these
trials limited further subgroup analyses of the PCI sub-population. In the NCDR registry,
which is the largest cohort of LAAO up to now, 20.3% of the LAAO patients had a prior
myocardial infarction. However, the proportion of stent implantation was not reported. Among
previous trials, the proportion of patients with coronary artery disease ranged from 28.5% to
47.5%. The large number of AF patients with CAD warrant the optimal stroke prevention
strategy to be assessed in this population.
The primary goal of the proposed study is to investigate if the non-inferiority would be met
for the LAAO when compared to NOACs in NVAF patients with PCI in terms of a composite
endpoint of any death, any stroke, any myocardial infarction, systemic embolism at 12 months.
In addition, the powered key secondary will also have 80% of power to show superiority for
the LAAO when compared to NOACs in terms of BARC type 2, 3, or 5 bleeding events at 36
months.